Surgical Packs, Kits and Trays

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K861530 ↗

FDA Product Code

FSM

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESD Substantially Equivalent — Deferred

• Mcd Specialty Brand Needle Counters

  Not classified

  FDA 510(k) K870044 Active Cleared 21 Jan 1987

• Disposable Surgical Drapes and Accessories

  Class II

  FDA 510(k) K861531 Active Cleared 23 May 1986

• Coloshield Colonoscopy Drape Model E2000

  Class II

  FDA 510(k) K020581 Active Cleared 18 Sep 2002

• Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650, D6651, D66XX

  Class II

  FDA 510(k) K000442 Active Cleared 24 Apr 2001

• Transparent Adhesive Dressing

  Class I

  FDA 510(k) K924794 Active Cleared 8 Jul 1993